Class II · ModerateActive recall
Clomipramine Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byZydus Lifesciences Ltd., Ahmedabad, India foreign manufacturer
| Brand name | CLOMIPRAMINE HYDROCHLORIDE |
| Generic name | CLOMIPRAMINE HYDROCHLORIDE |
| Active ingredient(s) | CLOMIPRAMINE HYDROCHLORIDE |
| Distributed by / for | Northstar Rx LLC, Memphis, TN 38141 |
| NDC | 16714-850-01 |
Show the full FDA record
| Full product label | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | Nationwide in the US |
| Quantity | N/A |
| Recall initiated | 2025-10-22 |
| Report date | 2025-11-12 |
| Recall completed | — |
| Recall number | D-0153-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.